Capturing IRB Protocol-Proposal Congruency For NIH research involving human subjects at Just-In-Time (JIT) Cynthia Kane, Associate Director Laura Kozma, Assistant Director Office of Grant and Contract Administration Cathleen Montano, IRB Manager Human Research Protection Program

Protocol application(s) must be reviewed and approved by the IRB Requirement: 45 CFR 46.103(f) Proposal for research involving human subjects must be reviewed and approved by the IRB + Protocol application(s) must be reviewed and approved by the IRB = CONGRUENCY

Congruency Proposal for Research Aims X, Y & Z Protocols funded by Proposal? Aims X & Z Aim Y Aim A Protocol #1 Protocol #2 Protocol #3

What’s Changing? Nothing but the business process The requirement is the same Responsibility for the Proposal and Protocol Principal Investigator(s) (PI) vs Department Business Offices Capturing of all protocols associated with a Proposal/Award and recorded in a central location IRES Proposal Tracking (PT)

What are the benefits? Decreased work for Department Administrators Minimize searching for Approval Letters Ensures protocol congruency data in place prior to Award

Formalized Existing Process Currently applies only to NIH proposals Prior to submitting JIT documentation Will be required beginning June 16th Form completed by Proposal PI Form submitted by Protocol PI(s) along with relevant IRB protocol documents (e.g., initial application or amendment request)

Form 100 FR.26 Yale University IRB Request for Protocol(s)-Proposal Congruency

Business Process Receipt of JIT Request Review and Submission of JIT JIT Checklist sent to Department Business Office (DBO) and Principal Investigator (PI) Proposal PI completes Form 100 FR26: Yale University Institutional Review Boards Request for Protocol(s)-Proposal Congruency Proposal PI (if also Protocol PI(s)) submits the Form 100 FR26 with relevant protocol documents to HIC/HSC; otherwise, Proposal PI forwards the Form 100 FR26 to the Protocol PI(s) to submit to the HIC/HSC along with relevant protocol documents for review and congruency determination Once determined congruent, the completed form is sent by the HRPP office to GCA for entry into IRES PT Review and Submission of JIT GCA Coordinator confirms that the form is uploaded and information is entered into the record If missing, the Coordinator will contact the DBO who will work with the PI to get the form submitted to the HIC/HSC If not completed by time of JIT submission deadline, if awarded, setup will be restricted in accordance with the terms and conditions until complete Laura

Roles and Responsibilities Department Business Office Works with the PI to ensure Form 100 FR26 is submitted to the HIC/HSC GCA Utilizes the JIT checklist to remind the PI of the requirement to submit the form to HIC/HSC Uploads form 100 FR26 and enters the protocol(s) approval, expiration, and congruency dates in IRES PT after the receipt of form from the HIC/HSC prior to the submission of JIT Proposal Principal Investigator (PI) Completes Form 100 FR26 and submits the form along with relevant protocol documents to the HIC/HSC – OR - Directs the Protocol PI(s) (if different from Proposal PI) to submit to HIC/HSC prior to the completion and submission of JIT Tracy

Roles and Responsibilities – cont’d HIC/HSC Conducts congruency review on all protocols listed on form Issues congruency determination to the protocol PI(s) via an approval letter Submits form 100 FR26 to GCA with congruency determination date

Timeline Date Activity June 1, 2014 Email communication sent to the research community June 6, 2014 G&C Alert sent June 10, 2014 Brown Bag June 16, 2014 New process is implemented June 23, 2014 August 2014 (TBD) Laura

Questions??

Resources GCA Cynthia Kane Associate Director 203-785-6762 cynthia.kane@yale.edu Laura Kozma Assistant Director 475-238-5276 laura.kozma@yale.edu HRPP Cathleen Montano IRB Manager 203-785-7182 cathleen.montano@yale.edu Laura